====== 知情同意 Informed Consent ======

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　　**知情同意**：指受试者被告知可影响其做出参加临床试验决定的各方面情况后，确认同意自愿参加临床试验的过程。该过程应当以书面的、签署姓名和日期的知情同意书作为文件证明。(([[法规:药物临床试验质量管理规范|药物临床试验质量管理规范]]. [[概念:国家药品监督管理局]]. 2020)) 

　　**Informed Consent**: A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.(([[法规:ich-gcp|ICH GCP (E6(R2))]]. [[概念:ICH]]. 2016))

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===== 扩展阅读 =====

　　**1. FDA: [[法规:知情同意指南|知情同意指南（Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors）]]**

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